Root Canal Treatment Outcome in Patients Under Bisphosphonate Therapy

May 23, 2020 updated by: Fausto Zamparini, University of Bologna

Root Canal Treatment of Compromised Teeth as Alternative Treatment in Patients Under Bisphosphonate Therapy: 60-month Results of a Prospective Clinical Study

The aim of this study was to evaluate the survival rate and healing time of compromised teeth and seriously compromised teeth that were endodontically treated in patients which received bisphosphonate therapy . Clinical complications, success and survival rate was reported. Mean clinical parameters, clinical symptoms and presence of periapical radilucency were recorded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was conducted in one University Endodontic Clinical Department - Dental School between January 2009 and December 2017.

Root canal treatment was performed according previously reported operative protocols.

Study Type

Observational

Enrollment (Actual)

111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Similar geographic provenience

Description

Inclusion Criteria:

  • Patients affected by endodontic disease and able to attend a hygiene recall program

Exclusion Criteria:

  • inability to attend a recall hygien program

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BPS group
patients under Bisphosphonate therapy for at least 24 months
Procedure: Root canal treatment
Root canal treatment using a standard manual k file instrumentation and carrier-based root canal filling technique
healthy patients
healthy patients not assuming with no previous Bisphosphonate assumption
Procedure: Root canal treatment
Root canal treatment using a standard manual k file instrumentation and carrier-based root canal filling technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
health patients
Time Frame: 5 years
assessment of periapical index (PAI)
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 5 years
extraction periapical re exacerbation during before the endline ( 5 years)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2009

Primary Completion (Actual)

December 15, 2016

Study Completion (Actual)

December 15, 2017

Study Registration Dates

First Submitted

May 20, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (Actual)

May 22, 2020

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 23, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bifosfonendo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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